Endoscopic treatment tool

ABSTRACT

An endoscopic treatment tool includes: a needle tube in which a needle tube insertion passage extending from a distal end to a proximal end of the needle tube is formed; a stylet which is disposed to move freely in the needle tube insertion passage; a main manipulation part which is connected to a proximal end side of the needle tube, the main manipulation part supporting the stylet such that the stylet advances while rotating, and the main manipulation part operating the stylet; a manipulation transmission member which has flexibility and the manipulation transmission member is connected to the stylet; and an auxiliary manipulation part which includes a handle fixed to a proximal end portion of the manipulation transmission member and the auxiliary manipulation part is configured such that the manipulation transmission member advances while rotating in accordance with a manipulation of the handle.

The present invention relates to an endoscopic treatment tool. Thisapplication is a continuation application based on PCT PatentApplication No. PCT/JP2016/062257, filed Apr. 18, 2016, whose priorityis claimed on Japanese Patent Application No. 2015-184392, filed Sep.17, 2015. The contents of both the PCT Patent Application and theJapanese Patent Application are incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention Description ofRelated Art

Conventionally, a method of indwelling a clip-like implant in a luminaltissue or the like to anastomose the luminal tissue has been known. Forexample, Japanese Patent No. 4801230 discloses an applicator whichindwells a coil spring-like implant in a living tissue and a method forindwelling an implant.

A tissue-fastening tool (an implant) disclosed in Japanese Patent No.4801230 is, for example, made of a highly elastic metal wire material,has a coil shape in a natural state, and is configured to be elasticallydeformable to be extended in a longitudinal direction by an externalforce. In the applicator and the method for indwelling the implantdisclosed in Japanese Patent No. 4801230, a tissue-fastening tool isinserted as an extended state, in a tubular member having a sharpinclined end surface at a distal end thereof. Next, in a state in whichthe inclined end surface of the tubular member is extruded from a sheathand the tubular member penetrates the living tissue, a part of thetissue-fastening tool in the longitudinal direction is extruded from thedistal end of the tubular member by a stylet. Thereafter, the tubularmember is removed from the tissue, and the remaining part of thetissue-fastening tool is extruded from the tubular member. When thetissue-fastening tool is extruded from the tubular member and indwelledin the tissue, the tissue-fastening tool is restored to a coil shape ata time of being formed to tighten a luminal tissue.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention, an endoscopictreatment tool includes: a needle tube in which a needle tube insertionpassage extending from a distal end to a proximal end of the needle tubeis formed; a stylet which is disposed to move freely in the needle tubeinsertion passage; a main manipulation part which is connected to aproximal end side of the needle tube, the main manipulation partsupporting the stylet such that the stylet advances while rotating, andthe main manipulation part operating the stylet; a manipulationtransmission member which has flexibility and the manipulationtransmission member is connected to the stylet; and an auxiliarymanipulation part which includes a handle fixed to a proximal endportion of the manipulation transmission member and the auxiliarymanipulation part being configured such that the manipulationtransmission member advances while rotating in accordance with amanipulation of the handle.

According to a second aspect of the present invention, in the endoscopictreatment tool according to the first aspect, the stylet and themanipulation transmission member may be separable from each other.

According to a third aspect of the present invention, the endoscopictreatment tool according to the first aspect may further include asheath in which a lumen extending from a distal end to a proximal end ofthe sheath is formed. The needle tube may be inserted into the lumen.

According to a fourth aspect of the present invention, the endoscopictreatment tool according to the first aspect may further include animplant which is connected to the stylet.

According to a fifth aspect of the present invention, in the endoscopictreatment tool according to the first aspect, the auxiliary manipulationpart may be disposed to be separate from the main manipulation part.

According to a sixth aspect of the present invention, the endoscopictreatment tool according to the third aspect may further include: astylet proximal end member which is fixed to a proximal end portion ofthe stylet; and an engagement part which protrudes from an outerperipheral surface of the stylet proximal end member. The mainmanipulation part may include a first cam tube which includes aninsertion passage formed along a longitudinal axis, and in which a firstguide passage is formed in a helical shape around a central axis of theinsertion passage. The stylet proximal end member may be inserted intothe insertion passage of the first cam tube. The endoscopic treatmenttool may be configured such that, when the manipulation transmissionmember is advanced while being rotated by the auxiliary manipulationpart, the engagement part moves while being engaged with the first guidepassage, so that the stylet rotates around a central axis of the sheathwhile advancing.

According to a seventh aspect of the present invention, in theendoscopic treatment tool according to the sixth aspect, the auxiliarymanipulation part may include a second cam tube in which a second guidepassage is formed in a helical shape at the same helical pitch and inthe same rotational direction as the first guide passage. The handle mayinclude a second projection which is engaged with the second guidepassage. The manipulation transmission member may advance while rotatingby the second projection moving while the second projection is engagedwith the second guide passage.

According to an eighth aspect of the present invention, in theendoscopic treatment tool according to the seventh aspect, a lead angleof the first guide passage may be equal to or more than 45 degrees, andthe lead angle of the first guide passage may be equal to or less than70 degrees.

According to a ninth aspect of the present invention, in the endoscopictreatment tool according to the first aspect, the main manipulation partmay include a first helical mechanism which outputs a helical motionaround a longitudinal central axis to the stylet. The auxiliarymanipulation part may include a second helical mechanism which outputs ahelical motion around a longitudinal central axis to the manipulationtransmission member. The endoscopic treatment tool may be configuredsuch that a helical motion of the manipulation transmission memberoutput by the second helical mechanism is transmitted to the stylet.

According to a tenth aspect of the present invention, the endoscopictreatment tool according to the first aspect may further include aneedle slider which is configured to manipulate the needle tube suchthat the needle tube advances or retracts. The stylet may be configuredto advance and retract while rotating with respect to the needle slider.

According to an eleventh aspect of the present invention, in theendoscopic treatment tool according to the first aspect, the mainmanipulation part may include a needle guide which includes a slitextending in a straight shape along a longitudinal axis, the needleguide freely rotating around a central axis of the needle tube relativeto the needle tube, and the needle guide being fixed in a central axialdirection of the needle tube relative to the needle tube, and a needleslider which freely rotates relative to the needle guide and the needleslider being fixed in a longitudinal axial direction of the needleguide. The endoscopic treatment tool may further include inside theneedle slider a stylet proximal end member which is fixed to a proximalend portion of the stylet, and an engagement part which protrudes froman outer peripheral surface of the stylet proximal end member and theengagement part being slidably engaged with the slit. The stylet may beconfigured to advance and retract while rotating with respect to theneedle slider in a state in which the engagement part is engaged withthe slit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view representing an example of an implantaccording to an embodiment of the present invention.

FIG. 2 is a diagram representing an example of a usage mode of theimplant of the embodiment of the present invention.

FIG. 3 is an overall diagram representing an endoscopic treatment toolaccording to the embodiment of the present invention.

FIG. 4 is a cross-sectional view of a distal end portion of theendoscopic treatment tool according to the embodiment of the presentinvention.

FIG. 5 is a perspective view of a main manipulation part according tothe embodiment of the present invention.

FIG. 6A is a cross-sectional view of the main manipulation partaccording to the embodiment of the present invention.

FIG. 6B is a cross-sectional view of a proximal end portion of the mainmanipulation part according to the embodiment of the present invention.

FIG. 6C is a cross-sectional view taken along line A-A in FIG. 6B.

FIG. 6D is a perspective view representing a state in which a needleguide is inserted into a sheath guide according to the embodiment of thepresent invention.

FIG. 7 is a cross-sectional view of a stylet and a first cam tubeaccording to the embodiment of the present invention.

FIG. 8 is a perspective view of a proximal end portion of the stylet anda distal end portion of a manipulation transmission member according tothe embodiment of the present invention.

FIG. 9 is a schematic view representing a first guide passage of thefirst cam tube according to the embodiment of the present invention.

FIG. 10 is a side view representing a state in which the stylet and astylet proximal end member are inserted into the needle guide accordingto the embodiment of the present invention.

FIG. 11 is a perspective view of a sheath slider according to theembodiment of the present invention.

FIG. 12 is a partial cross-sectional view of the main manipulation partaccording to the embodiment of the present invention.

FIG. 13 is a side view of an auxiliary manipulation part according tothe embodiment of the present invention.

FIG. 14A is a cross-sectional view of the auxiliary manipulation partaccording to the embodiment of the present invention.

FIG. 14B is a cross-sectional view of a manipulation connection partaccording to the embodiment of the present invention.

FIG. 15 is a diagram representing a relationship between the first guidepassage and a second guide passage according to the embodiment of thepresent invention.

FIG. 16 is a flowchart of a procedure in which the endoscopic treatmenttool according to the embodiment of the present invention is used.

FIG. 17 is a side view representing an initial state of the mainmanipulation part according to the embodiment of the present invention.

FIG. 18 is a perspective view of a jig according to the embodiment ofthe present invention.

FIG. 19 is a diagram representing a state in which the endoscopictreatment tool according to the embodiment of the present invention isattached to an endoscope.

FIG. 20 is a side view representing a usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

FIG. 21 is a side view representing the usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

FIG. 22 is a side view representing the usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

FIG. 23 is a side view representing the usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

FIG. 24 is a side view representing the usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

FIG. 25 is a side view representing the usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

FIG. 26 is a side view representing the usage mode of the endoscopictreatment tool according to the embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

An endoscopic treatment tool according to an embodiment of the presentinvention will be described. In the present embodiment, an example of animplant-indwelling device (hereinafter simply referred to as an“indwelling device”) will be described as an endoscopic treatment tool.

First, an implant which is loaded in an implant-indwelling device 1 andindwelled in the body will be described. As the implant, it is possibleto use a known implant which is made of a highly elastic metal wirematerial, has a curved shape in advance, is elastically deformable, andhas a restoring force restoring the implant to the curved shape. In thepresent embodiment, as represented in FIG. 1, an example (see FIGS. 20to 26) is represented in which a tissue-fastening tool 2 that is formedby winding one shape memory wire in a coil shape and that sandwiches andanastomoses two luminal tissues of a tissue D of a duodenum and a tissueCBD of a common bile duct in a close-contact state as represented inFIG. 2 is indwelled as an implant.

The tissue-fastening tool (a treatment part) 2 includes animplant-coupling part (a coupling part) 22 at a proximal end 21 thereof.As represented in FIG. 1, the implant-coupling part 22 has a firstengagement part main body 23 and a recessed part 24. The firstengagement part main body 23 has a semicircular pillar-shaped partobtained by cutting a cylinder in half along a central axis thereof. Therecessed part 24 is a hole formed to extend in a perpendicular directionfrom a planar part 23 a parallel to a longitudinal axis of the firstengagement part main body 23. The implant-coupling part 22 is configuredto be engageable with a stylet to be described later.

FIG. 3 is an overall diagram representing the indwelling device 1according to this embodiment. The indwelling device 1 is a device forindwelling the tissue-fastening tool 2 in a body using an endoscope. Theindwelling device 1 has a sheath 3, a needle tube (an elongated shaftand a treatment part) 4, a stylet (a treatment part) 5, a mainmanipulation part 6, an auxiliary manipulation part 7, and amanipulation transmission member (hereafter, referred to as a“transmission member” in some cases) 8. The sheath 3, the needle tube 4,the stylet 5, and the main manipulation part 6 are disposed on a centralaxis L of the sheath 3. The auxiliary manipulation part 7 is coupled tothe main manipulation part 6 on the central axis L of the sheath 3. Inthe following description of the main manipulation part 6 and theauxiliary manipulation part 7, the term “central axis” is used with ameaning including an extension line of the central axis L of the sheath3 when the main manipulation part 6 and the auxiliary manipulation part7 are disposed on the central axis L of the sheath 3.

FIG. 4 is a cross-sectional view of a distal end portion of theindwelling device 1. The sheath 3 is a part which is inserted into abody. As represented in FIGS. 3 and 4, a lumen 31 is formed inside thesheath 3 and extends from a distal end thereof to a proximal endthereof. As represented in FIG. 4, a notched part 33 extending in adirection of the central axis L is formed in a distal end openingportion 32 of the sheath 3. The needle tube 4 to be described later isinserted into the sheath 3 so as to freely advance and retract. Aproximal end side of the sheath 3 is connected to the main manipulationpart (the manipulation part) 6. The sheath 3 is inserted into atreatment tool channel 102 of an endoscope insertion part 101 (see FIG.20).

As represented in FIG. 4, the needle tube 4 is a long member having ahollow needle tube insertion passage (an insertion passage) 41. Theneedle tube 4 is inserted into the lumen 31 to be projectable andretractable from a distal end of the sheath 3. A distal end (apuncturing part) 42 of the needle tube 4 is formed to be sharp andfunctions as a puncture needle. A proximal end of the needle tube 4 isattached to a distal end of a needle guide 67 (see FIG. 6A), which willbe described later, to be relatively rotatable and immovable forward andbackward. A superelastic alloy represented by a nickel titanium alloy orstainless steel can be adopted, for example, as a material of the needletube 4.

The stylet 5 is a long core material, a distal end portion thereof islocated inside the needle tube insertion passage 41 (see FIG. 4), and aproximal end portion thereof extends to the main manipulation part 6provided on the proximal end side of the sheath 3. The stylet 5 is amember which advances and retracts the tissue-fastening tool 2 withrespect to the needle tube insertion passage 41. The stylet 5 isconfigured to be projectable and retractable from the distal end of thesheath 3.

FIG. 7 is a cross-sectional view of the stylet 5 and a first cam tube (acam tube) 61. As represented in FIG. 7, a distal end engagement part 51is provided at a distal end portion of the stylet 5. The distal endengagement part 51 has a second engagement part main body 51 a and aprotruding part 51 b. A proximal end portion of the second engagementpart main body 51 a has a cylindrical shape, and a distal end portionthereof has a semi-cylindrical shape in which a cylinder is cut in halfon the central axis L. The protruding part 51 b is formed to protrude ina perpendicular direction from a planar part 51 c of the secondengagement part main body 51 a parallel to the central axis L. Asrepresented in FIG. 4, when the planar parts 23 a and 51 c come intocontact with each other inside the needle tube 4 and the protruding part51 b is inserted into the recessed part 24, the distal end engagementpart 51 and the implant-coupling part 22 engage with each other and thetissue-fastening tool 2 is coupled to the stylet 5.

As represented in FIG. 7, a stylet proximal end member 54 is fixed tothe proximal end portion of the stylet 5. Three first engaging pins (camfollowers and first projections) 55 are provided at a distal end portionof the stylet proximal end member 54 to protrude in a directionorthogonal to the central axis L. The three first engaging pins 55 areprovided to be spaced part at an equal angle in a circumferentialdirection and spaced apart at an equal interval in the direction of thecentral axis L.

FIG. 6A is a cross-sectional view of the main manipulation part 6. FIG.6B is a cross-sectional view of a proximal end portion of the mainmanipulation part 6. As represented in FIGS. 6A, 6B, and 7, the styletproximal end member 54 is inserted through a lumen 571 of a Luer joint57. FIG. 8 is a perspective view of the proximal end portion of thestylet 5 and a distal end portion of the transmission member 8. Aproximal end engagement part 56 is provided on the stylet proximal endmember 54. The proximal end engagement part 56 is an engagement memberthat engages with the distal end portion of the transmission member 8.As represented in FIG. 8, the proximal end engagement part 56 has asubstantially flat plate shape and is provided to extend along thecentral axis L from a proximal end of the stylet proximal end member 54.A proximal end portion 56 a of the proximal end engagement part 56 has asurface which protrudes toward a proximal end side. A through-hole 56 bis formed in the proximal end engagement part 56.

The proximal end engagement part 56 has a size such that the proximalend engagement part 56 is located inside a maximum outer diameter partof the stylet 5 when viewed from the direction of the central axis L.

As represented in FIG. 4, the stylet 5 and the needle tube 4 areinserted through the lumen 31 of the sheath 3 so as to be coaxial withthe central axis L of the sheath 3. The sheath 3, the needle tube 4, andthe stylet 5 are members that are inserted into a body from a distal endside, and are made of materials that are elastically deformable alongwith bending of the treatment tool channel 102 when inserted through thetreatment tool channel 102 of the endoscope 100.

The main manipulation part 6 is provided along the central axis L of thesheath 3 on the proximal end side of the sheath 3. FIG. 5 is aperspective view of the main manipulation part 6. FIG. 6C is across-sectional view taken along line A-A in FIG. 6B. FIG. 3 representsthe main manipulation part 6 in a state in which a jig 9 to be describedlater is mounted thereon. FIGS. 5, 6A, 6B, and 6C illustrate the mainmanipulation part 6 from which the jig 9 is removed. The mainmanipulation part 6 is provided to operate the sheath 3, the needle tube4, and the stylet 5. The main manipulation part 6 includes the first camtube 61, a main manipulation part main body 62, a sheath slider 63, aneedle slider (a slider unit and an elongated shaft manipulation part)64, a needle slider stopper 65, a first rotation knob (an elongatedshaft manipulation part) 66, the needle guide 67, and a mounting part69.

As represented in FIG. 7, the first cam tube 61 is a tube in which afirst insertion passage 611 extending along the central axis L and afirst guide passage (a cam and a guide passage) 612 are formed. Thefirst guide passage 612 communicates with an inside and outside of atube and is formed in a helical shape. The helical shape of the firstguide passage 612 is formed such that the first engaging pin 55 advancesfrom a proximal end of the first guide passage 612 to a distal endthereof while rotating clockwise when viewed from the proximal endtoward the distal end.

FIG. 9 is a schematic view representing the helical shape of the firstguide passage 612. As represented in FIG. 9, the helical shape of thefirst guide passage 612 is formed at a constant pitch. A helical pitch Pof the helical shape of the first guide passage 612 is formed at a pitchwhich is equal to a length obtained by dividing a length of the wirematerial of a coil in a part of the tissue-fastening tool 2 indwelled ina luminal organ on a proximal side by the number of turns of the coil ofthat part. Further, the number of turns of the helical shape of thefirst guide passage 612 is set to be greater than or equal to the numberof turns of a partial coil that is indwelled in the luminal organ on theproximal side of the tissue-fastening tool 2. Furthermore, a lead angleθ of the first guide passage 612 is set within a range of 20 degrees ormore to 75 degrees or less.

As represented in FIGS. 6A and 7, the proximal end portion of the stylet5 and the stylet proximal end member 54 are inserted into the first camtube 61. The first cam tube 61 and the three first engaging pins 55 ofthe stylet proximal end member 54 constitute a first helical mechanism80. The three first engaging pins 55 of the stylet proximal end member54 are inserted into the first guide passage 612 to protrude outwardfrom the first insertion passage 611. By the engagement between thethree first engaging pins 55 and the first guide passage 612, the stylet5 and the stylet proximal end member 54 are configured to be supportedby the first cam tube 61 and to advance and retract while rotating withrespect to the first cam tube 61. In this way, the helical mechanismdefines the motion of the stylet 5.

A proximal end portion of the first cam tube 61 and a distal end portionof the Luer joint 57 are fixed to each other. The Luer joint 57 and thestylet 5 are configured to be relatively rotatable. The stylet 5 and thestylet proximal end member 54 can advance and retract in the directionof the central axis L while rotating with respect to the first cam tube61 and the Luer joint 57.

FIG. 10 is a side view representing a state in which the first cam tube61, the stylet 5, and the stylet proximal end portion are inserted intothe needle guide 67. FIG. 6D is a perspective view representing a statein which the needle guide 67 is inserted into a sheath guide 623. Asrepresented in FIG. 10, the needle guide 67 has a substantiallycylindrical shape, and as represented in FIG. 6A, has a needle guideinsertion passage 671 which extends in the direction of the central axisL. As represented in FIGS. 6D and 10, on a side wall part 672 of theneedle guide 67, a guide slit 673 communicating the outside of theneedle guide 67 and the inside of the needle guide insertion passage 671is formed along the direction of the central axis L. Three guide slits673 are formed at equal intervals in a circumferential direction of theneedle guide 67.

As represented in FIG. 6A, the needle guide insertion passage 671 isformed with a small-diameter part 671 a having a small opening diameterof the needle guide insertion passage 671 in a partial region in thedirection of the central axis L. The opening diameter of thesmall-diameter part 671 a is set to be slightly larger than an outerdiameter of the first cam tube 61.

The needle slider end member 643 is fixed to a proximal end of theneedle slider 64. The needle guide 67 is sandwiched between the needleslider 64 and the needle slider end member 643 at a proximal endportion, and is supported to be capable of only rotating with respect tothe needle slider 64.

The stylet 5, the stylet proximal end member 54, the first cam tube 61,and the Luer joint 57 are inserted into the needle guide insertionpassage 671 to be advanceable and retractable with respect to the needleguide 67. When the first cam tube 61 is inserted through thesmall-diameter part 671 a of the needle guide 67, the first cam tube 61is supported to be relatively advanceable, retractable, and rotatable onthe central axis L inside the needle guide insertion passage 671.

As represented in FIG. 10, the three first engaging pins 55 of thestylet proximal end member 54 are respectively engaged with the guideslits 673. The first engaging pin 55 is slidable inside the guide slit673. That is, the first engaging pin 55 is slidable inside the firstguide passage 612 and inside the guide slit 673.

The first cam tube 61 is supported to be capable of only advancing andretracting with respect to the needle slider 64. The first engaging pin55 of the stylet proximal end member 54 is simultaneously engaged withthe first guide passage 612 and the guide slit 673. In other words, thefirst helical mechanism 80 including the first cam tube 61 and the firstengaging pin 55 is supported by the needle slider 64 and is engaged withthe guide slit 673. When the stylet 5 and the stylet proximal end member54 rotate around the central axis L, the stylet 5 and the styletproximal end member 54 advance and retract with respect to the needleslider 64 while rotating, and the needle guide 67 is configured to onlyrotate. In this description, a motion in which the stylet 5 advanceswhile rotating is referred to as a “helical motion” in some cases.

As represented in FIG. 5, the main manipulation part main body 62 has asubstantially cylindrical shape, and as represented in FIG. 6A, a secondinsertion passage 621 extending in the direction of the central axis Lis formed in the main manipulation part main body 62. A sheath guide 623is inserted into a distal end side of the second insertion passage 621.The sheath guide 623 is rotatably supported with respect to the mainmanipulation part main body 62 near a distal end of the second insertionpassage 621. A sheath fixing part 625 is fixed to a distal end portionof the sheath guide 623, and the proximal end of the sheath 3 is fixedto the sheath fixing part 625.

As represented in FIG. 6D, the sheath guide 623 is a substantiallycylindrical member extending in the direction of the central axis L, andas represented in FIG. 6A, a third insertion passage 623 a is formedtherein. The stylet 5 inserted through the needle guide 67 and the firstcam tube 61 is inserted through the third insertion passage 623 a to beadvanceable and retractable. In the sheath guide 623, first slits 623 bextending in the direction of the central axis L are formed at threepositions at equal intervals in the circumferential direction. The firstslits 623 b are engaged with ribs 673 a (see FIG. 10) formed on theradial outside of the circumference of the guide slit 673 of the needleguide 67. Therefore, when the needle guide 67 rotates around the centralaxis L, the sheath guide 623 rotates to follow the rotation. However,even if the needle guide 67 advances and retracts in the direction ofthe central axis L, the sheath guide 623 does not follow the movement.From the above, the first helical mechanism 80 rotates the sheath 3around the central axis L due to the engagement between the cam and thecam follower.

The ring-shaped needle slider stopper 65 is externally mounted on themain manipulation part main body 62. The needle slider stopper 65 has aninner diameter that enables the needle slider stopper 65 to advance andretract in the direction of the central axis L with respect to the mainmanipulation part main body 62. A screw hole 651 is formed on the needleslider stopper 65. A needle stopper screw 652 is screwed into the screwhole 651. When the needle stopper screw 652 is inserted and screwed intothe screw hole 651, a distal end of the needle stopper screw 652 pressesan outer peripheral surface of the main manipulation part main body 62and a position of the needle slider stopper 65 with respect to the mainmanipulation part main body 62 is fixed.

The sheath slider 63 is provided on a distal end side of the mainmanipulation part main body 62. As represented in FIGS. 5 and 11, thesheath slider 63 is a cylindrical member, and a fourth insertion passage632 extending in the direction of the central axis L from a proximal endopening 631 is formed thereon. A distal end portion of the mainmanipulation part main body 62 is inserted into the proximal end opening631. The main manipulation part main body 62 is provided to beadvanceable and retractable inside the fourth insertion passage 632.

The mounting part 69 is fixed to a distal end of the sheath slider 63.The mounting part 69 is fixed to a manipulation part 104 of theendoscope 100 by being screw-engaged with a port 103 of the treatmenttool channel 102 of the endoscope 100 (see FIG. 19). The mainmanipulation part 6 is fixed to the endoscope 100 by the mounting part69. A distal end insertion passage 691 extending in the direction of thecentral axis L is formed in the mounting part 69. The sheath 3 isinserted through the distal end insertion passage 691 to be advanceableand retractable. The sheath 3 can be advanced and retracted by movingthe main manipulation part main body 62 to advance and retract in alinear direction with respect to the sheath slider 63.

A second slit 633 extending in the direction of the central axis L isformed in the sheath slider 63. A fixing knob 634 is inserted into thesecond slit 633 from an outer peripheral side thereof. A screw part 634a of the fixing knob 634 passes through the second slit 633 andprotrudes toward a side of the fourth insertion passage 632 of thesheath slider 63. A distal end of the screw part 634 a of the fixingknob 634 is inserted into a screw hole 623 d formed on an outerperiphery of the distal end portion of the main manipulation part mainbody 62. A length of the screw part 634 a is set such that a screw head634 b of the fixing knob 634 can be slightly separated from the secondslit 633 while maintaining a state in which a part of a distal end sideof the screw part 634 a is screwed into the screw hole of the mainmanipulation part main body 62.

When the screw part 634 a is screwed into a side of the mainmanipulation part main body 62, the sheath slider 63 around the secondslit 633 is clamped by the screw head 634 b and the main manipulationpart main body 62. As a result, a positional relationship between thesheath slider 63 and the main manipulation part main body 62 in thedirection of the central axis L is fixed. When screwing of the screwpart 634 a is loosened, the main manipulation part main body 62 is in astate that is capable of advancing and retracting in the lineardirection with respect to the sheath slider 63. That is, relativepositions of the main manipulation part main body 62 to the sheathslider 63 can be switched into a fixed state or a relatively movablestate due to the second slit 633 and the fixing knob 634.

Depending on a position of the fixing knob 634 with respect to thesecond slit 633, an amount of protrusion of the sheath 3 from the mainmanipulation part 6 (an amount of protrusion from the mounting part 69)is determined. A length of the second slit 633 in the direction of thecentral axis L corresponds to an advancement and retraction movementlength of the sheath 3. When the fixing knob 634 is disposed at aposition at which it comes into contact with a distal end of the secondslit 633, the amount of protrusion of the sheath 3 from a distal end ofthe main manipulation part 6 (the amount of protrusion from the mountingpart 69) is maximized. Meanwhile, when the fixing knob 634 is disposedat a position at which it comes into contact with a proximal end of thesecond slit 633, the sheath 3 is disposed at a maximally retractedposition, and the amount of protrusion of the sheath 3 from the distalend of the main manipulation part 6 is minimized.

As represented in FIGS. 5 and 11, a resin spring 635 configured of acantilever extending in the direction of the central axis L is providedin a part of the second slit 633 of the sheath slider 63. As representedin FIG. 11, the resin spring 635 is provided with an inclined surface635 a and a locking surface 635 b. When the fixing knob 634 is advancedto a distal end side in the direction of the central axis L, the screwpart 634 a comes in contact with the inclined surface 635 a and advanceswhile gradually pressing the resin spring 635, and comes into contactwith the distal end 633 a of the second slit 633. The screw part 634 ais disengaged from the inclined surface 635 a when coming into contactwith the distal end 633 a of the second slit 633, and the resin spring635 returns to an original position thereof. Even if a force returningthe fixing knob 634 to a proximal end side in the direction of thecentral axis L acts in this state, because the screw part 634 a hits thelocking surface 635 b, the screw part 634 a does not return because thescrew part 634 a comes into contact with the locking surface 635 b. Asdescribed above, even if the screw part 634 a is not screwed into themain manipulation part main body 62, the sheath slider 63 can be fixedwhile the amount of protrusion of the sheath 3 from the mainmanipulation part 6 is maximized.

As represented in FIGS. 5 and 6A, the needle slider 64 has asubstantially cylindrical shape and is provided along the central axis Lin an intermediate part of the main manipulation part 6 in the directionof the central axis L. In a fifth insertion passage 641 formed in theneedle slider 64, the stylet 5, the first cam tube 61, the needle guide67, and the main manipulation part main body 62 are sequentiallycoaxially disposed from a side of the central axis L toward the outsidein the radial direction. The first rotation knob 66, which will bedescribed later, is disposed at a proximal end portion of the needleslider 64.

As represented in FIG. 12, a pair of side holes 642 are formed in theneedle slider 64 such that they are opposed to each other in the radialdirection. As represented in FIGS. 5 and 12, a slide button unit 68 isprovided in each of the pair of side holes 642. The slide button unit 68is provided to switch between a state in which the needle slider 64 canadvance and retract in the direction of the central axis L with respectto the main manipulation part main body 62 and a state in which theneedle slider 64 can advance and retract while rotating around thecentral axis L. The upper side of FIG. 12 represents the slide buttonunit 68 in a state in which the needle slider 64 can advance and retractin the direction of the central axis L with respect to the mainmanipulation part main body 62, and the lower side of FIG. 12 representsthe slide button unit 68 in a state in which the needle slider 64 canadvance and retract while rotating around the central axis L withrespect to the main manipulation part main body 62. Actually, the pairof slide button units 68 is switched to one of a state represented onthe upper side of FIG. 12 or a state represented on the lower side ofFIG. 12.

A base body 681 of the slide button unit 68 is fitted into the side hole642 and fixed to the needle slider 64, and a button main body 682 isattached to the radial outside of the base body 681. A spring member 683is provided as a biasing member between the button main body 682 and thebase body 681. The button main body 682 is biased in a direction awayfrom the base body 681 toward the outer side in the radial direction bythe spring member 683.

The slide button unit 68 further includes a plate 684 between the buttonmain body 682 and the base body 681. The plate 684 is disposed to extendin the direction of the central axis L, and a substantially intermediatepart of the plate 684 in the direction of the central axis L is fixed tothe base body 681. A hole 681 b formed along the central axis L isformed in the base body 681. A distal end portion of the plate 684 isengaged with the slit 682 a of the button main body 682, and a proximalend portion of the plate 684 is disposed in the hole 681 b of the basebody 681. A first surface 684 a of the plate 684 faces the button mainbody 682, and a second surface 684 b is located in the hole 681 b anddisposed to face the main manipulation part main body 62. A locking pin684 c is provided at the proximal end portion of the plate 684 toprotrude from the second surface 684 b in a thickness direction of theplate 684. A helical groove 622 is formed on an outer peripheral surfaceof an intermediate region of the main manipulation part main body 62 inthe direction of the central axis L, and the locking pin 684 c isswitched between a state of being engaged with the helical groove 622and a state of not being engaged with the helical groove 622 asrepresented in FIG. 12.

When an operator pushes the button main body 682 inward in the radialdirection and pushes the button main body 682 until it comes intocontact with the base body 681, the distal end portion of the plate 684is pressed toward the side of the main manipulation part main body 62.Accordingly, the proximal end portion of the plate 684 moves in adirection away from the main manipulation part main body 62 and thelocking pin 684 c is detached from the helical groove 622. In thisstate, because a connection relationship between the needle slider 64and the main manipulation part main body 62 is released, the needleslider 64 is configured to be advanceable and retractable in thedirection of the central axis L with respect to the main manipulationpart main body 62.

In a state in which the spring member 683 biases the button main body682 outward in the radial direction and the button main body 682 isseparated from the base body 681, the button main body 682 pulls thedistal end portion of the plate 684 outward in the radial direction andthe proximal end portion of the plate 684 is biased toward the side ofthe main manipulation part main body 62. At this time, the locking pin684 c is fitted into the helical groove 622 formed on the outerperipheral surface of the main manipulation part main body 62. In thisstate, the needle slider 64 is configured to be advanceable andretractable while rotating with respect to the main manipulation partmain body 62.

The first rotation knob 66 is a member that is rotationally manipulatedby the operator when sending the tissue-fastening tool 2 from the distalend of the needle tube 4. As represented in FIGS. 5, 6A, 6B, and 6C, thefirst rotation knob 66 is a cylindrical member and is attached to covera side surface and a proximal end side of the needle slider end member643. The first rotation knob 66 is rotatably attached to the needleslider end member 643. A female screw 661 is formed at the center of thefirst rotation knob 66, and is engaged with a male screw 572 which iscut around an outer periphery of the Luer joint 57. An engagingprojection 643 b that protrudes in the radial direction is formed in athrough-hole 643 a which is a substantial center of the needle sliderend member 643. A linear groove 573 extending in the direction of thecentral axis L is formed on the outer periphery of the Luer joint 57.The engaging projection 643 b is engaged with the linear groove 573.With this configuration, the Luer joint 57 and the first cam tube 61fixed to the Luer joint 57 are advanced and retracted with respect tothe first rotation knob 66 by the first rotation knob 66 being rotated.At the same time, the stylet 5 engaged with the first cam tube 61 isadvanced and retracted with respect to the first rotation knob 66.

FIG. 13 is a side view of the auxiliary manipulation part 7 when viewedfrom a direction orthogonal to the central axis L. The auxiliarymanipulation part 7 is disposed to be separated from the mainmanipulation part 6 and is connected to the main manipulation part 6 viathe transmission member 8. The main manipulation part 6 and theauxiliary manipulation part 7 are configured to be separably connectedvia the transmission member 8. The auxiliary manipulation part 7advances and retracts the transmission member 8 to manipulate themovement of the stylet 5 within the main manipulation part 6. Theauxiliary manipulation part 7 includes a manipulation coupling part 71,an auxiliary manipulation part main body 72, a second cam tube 73, and arotation handle 74 in order from a distal end side thereof, and thetransmission member 8 is inserted throughout the entire length in thedirection of the central axis L.

FIG. 14A is a cross-sectional view of the auxiliary manipulation part 7in a plane passing through the central axis L. FIG. 14B is across-sectional view of the manipulation coupling part 71. Themanipulation coupling part 71 is a member that is connected to theproximal end portion of the main manipulation part 6 and couples theproximal end portion of the stylet 5 and the distal end portion of thetransmission member 8. A sixth insertion passage 711 extending in thedirection of the central axis L is formed in the manipulation couplingpart 71. A screw groove 712 capable of being screwed to a flange 574 ofthe Luer joint 57 (see FIG. 5) is formed around the central axis L on aninner peripheral surface of a distal end portion of the sixth insertionpassage 711.

The transmission member 8 is a long and flexible core material (aflexible member). A distal end side from a substantially central part ofthe transmission member 8 in the direction of the central axis L isinserted into a cable tube 81 having flexibility. The transmissionmember 8 is a transmission member that transmits a manipulation input ofthe auxiliary manipulation part 7 on the rotation handle 74 to the mainmanipulation part 6.

As represented in FIG. 8, a stylet engagement part 82 is provided at thedistal end of the transmission member 8. The stylet engagement part 82has two arms 82 b extending in parallel with the direction of thecentral axis L from a base part 82 a having a substantially columnarouter shape. The two arms 82 b have planar parts 82 c and 82 d that faceeach other across the central axis L. A separation distance between theplanar parts 82 c and 82 d in the radial direction (a directionorthogonal to the central axis L) is set to be slightly larger than aplate thickness of the proximal end engagement part 56 of the mainmanipulation part 6.

The transmission member 8 is inserted into the sixth insertion passage711 to be advanceable, retractable, and rotatable with respect to themanipulation coupling part 71. In a state in which the auxiliarymanipulation part 7 is not coupled to the main manipulation part 6, thedistal end of the transmission member 8 is disposed at a substantiallyintermediate part of the sixth insertion passage 711 in the direction ofthe central axis L.

The stylet engagement part 82 is configured so that the stylet 5 and thetransmission member 8 are engaged with each other when the proximal endengagement part 56 is inserted between the two arms 82 b on the centralaxis L. When the stylet 5 and the transmission member 8 are engaged witheach other, the planar parts 82 c and 82 d come into contact with theproximal end engagement part 56, and the rotational motion of thetransmission member 8 can be transmitted to the stylet 5. Further, thestylet 5 can advance when the transmission member 8 advances.

The auxiliary manipulation part main body 72 has a tubular shape and isdisposed on a distal end side of the auxiliary manipulation part 7. Asrepresented in FIG. 14A, a seventh insertion passage 721 extending inthe direction of the central axis L is formed in the auxiliarymanipulation part main body 72. The seventh insertion passage 721includes a first region 721 a on a proximal end side thereof, and asecond region 721 b which is located on a distal end side from the firstregion 721 a and has an opening diameter smaller than an openingdiameter of the first region 721 a. A first ring member 723 isexternally fixed to an outer peripheral surface of a proximal endportion of the auxiliary manipulation part main body 72 and is fixed bya screw 724.

A connector 725 is fixed to a distal end portion of the auxiliarymanipulation part main body 72. Specifically, the connector 725 isinserted to block a distal end opening of the second region 721 b of theseventh insertion passage 721 and is fixed to the auxiliary manipulationpart main body 72. An eighth insertion passage 726 is formed in theconnector 725 along the central axis L, and a distal end portion of aguide tube 75 to be described later is fixed to a proximal end side ofthe eighth insertion passage 726. The cable tube 81 is fixed to a distalend side of the eighth insertion passage 726. The transmission member 8is inserted into the guide tube 75 and the cable tube 81 fixed in theeighth insertion passage 726 and extends to the manipulation couplingpart 71.

The second cam tube 73 is a long tubular member, and a second guidepassage 731 configured of a groove that is formed in a helical shapearound the central axis L is formed on an outer circumferential surfaceof the second cam tube 73. As represented in FIG. 15, the second guidepassage 731 of the second cam tube 73 and the first guide passage 612 ofthe first cam tube 61 are formed at the same helical pitches P1 and P2and in the same rotational direction. A distal end side of the secondcam tube 73 is inserted through the first region 721 a of the seventhinsertion passage 721 of the auxiliary manipulation part main body 72,and a distal end portion of the second cam tube 73 is fixed to thesecond region 721 b.

As represented in FIG. 14A, a gap S is formed between an innerperipheral surface of the first region 721 a and an outer peripheralsurface of the second cam tube 73. The second cam tube 73 has a caminsertion passage 732 extending in the direction of the central axis L.The cam insertion passage 732 is formed with a reduced diameter part 732a in which an opening diameter is reduced in a substantially centralpart in the direction of the central axis L.

The guide tube 75 having a length substantially equal to that of thesecond cam tube 73 is inserted into the cam insertion passage 732. Adistal end portion of the guide tube 75 is fixed to the eighth insertionpassage 726 of the connector 725 as described above. Since a proximalend side of the guide tube 75 is inserted through the reduced diameterpart 732 a of the cam insertion passage 732, the guide tube 75 isarranged so that a center thereof coincides with the central axis L. Thetransmission member 8 is inserted in the guide tube 75 to be advanceableand retractable. With this configuration, the transmission member 8 issupported on the central axis L to be advanceable and retractable withinthe auxiliary manipulation part 7.

As represented in FIGS. 13 and 14A, the rotation handle 74 is a tubularmember, and is disposed at a proximal end portion of the auxiliarymanipulation part 7. A ninth insertion passage 741 extending in thedirection of the central axis L is formed in the rotation handle 74. Anopening diameter of a distal end side region of the ninth insertionpassage 741 is set to be slightly larger than an outer diameter of thesecond cam tube 73. Three screw holes 742 communicating an outerperipheral surface and the inside of the ninth insertion passage 741 areformed at a distal end portion of the rotation handle 74 (two screwholes 742 are not represented in FIG. 14A). Each of the screw holes 742is provided at the same interval in the circumferential direction atevery ⅓ turn (an angle of 120 degrees), and is provided at the sameinterval in the longitudinal direction at every ⅓ length of theaforementioned helical pitch.

The second cam tube 73 is inserted into the ninth insertion passage 741.In the state in which the second cam tube 73 is inserted into the ninthinsertion passage 741 of the rotation handle 74, a second engaging pin743 is screwed and fixed to each of the screw holes 742. Each of thescrew holes 742 protrudes into the ninth insertion passage 741, and adistal end portion thereof is engaged with the inside of the secondguide passage 731. An outer diameter of a distal end portion of thesecond engaging pin 743 is smaller than an opening width of the secondguide passage 731. Therefore, the distal end portion of the secondengaging pin 743 is configured to be relatively movable inside thesecond guide passage 731 in accordance with the rotation of the rotationhandle 74. The second cam tube 73 and the second engaging pin 743constitute a second helical mechanism 90.

A fixing member 744 that covers a proximal end opening of the ninthinsertion passage 741 is fixed to a proximal end portion of the rotationhandle 74. The proximal end portion of the transmission member 8 and theproximal end portion of the rotation handle 74 are fixed to each otherby the fixing member 744. Therefore, the proximal end portion of thetransmission member 8 follows the manipulation of the rotation handle74. That is, the second helical mechanism 90 advances the transmissionmember 8 while rotating the transmission member 8 with respect to theauxiliary manipulation part main body 72.

A second ring member 745 is externally fixed to an outer peripheralsurface of a substantially central part of the rotation handle 74 in thedirection of the central axis L and is fixed by a screw 746. An outerdiameter of the rotation handle 74 on a distal end side of the secondring member 745 is set to be slightly smaller than the opening diameterof the first region 721 a of the seventh insertion passage 721.

In the indwelling device 1 having the aforementioned configuration, themain manipulation part 6 can perform various manipulations such asadvancement, retraction, and rotation of the sheath 3, advancement andretraction of the needle tube 4, and advancement, retraction, androtation of the stylet 5. The auxiliary manipulation part 7 isconfigured such that advancement, retraction, and rotationalmanipulation of the transmission member 8 can be performed andmanipulation on the needle tube 4 may not be performed.

Next, regarding the motion of the indwelling device 1, an example of aprocedure of mounting the indwelling device 1 to an ultrasonic endoscope(hereinafter referred to as an “endoscope”) and indwelling thetissue-fastening tool 2 to penetrate the tissue D of a duodenum and thetissue CBD of a common bile duct will be described. FIG. 16 is aflowchart representing the procedure of this embodiment.

The indwelling device 1 is configured such that a motion (a firstmotion) of moving the stylet 5 from the proximal end side to the distalend side with respect to the needle tube 4 can be manipulated by both ofthe main manipulation part 6 and the auxiliary manipulation part 7.Meanwhile, the indwelling device 1 is configured such that amanipulation (a second motion) of the needle tube 4 is performed only inthe main manipulation part 6. This will be described in detail below.

FIG. 17 is a side view representing an initial state of the mainmanipulation part 6. As represented in FIG. 17, in the tissue-fasteningtool 2, the distal end portion of the stylet 5 and the proximal endportion of the tissue-fastening tool 2 are engaged with each otherinside the needle tube insertion passage 41 of the distal end portion ofthe needle tube 4 inserted into the sheath 3. The tissue-fastening tool2 is provided to be projectable and retractable from the distal end ofthe needle tube 4. As represented in FIG. 17, a part of thetissue-fastening tool 2 located on a side closer to the distal end thanthe connection part with the stylet 5 protrudes from the distal end ofthe needle tube 4 and is disposed in a state in which a coil shapethereof is restored.

The main manipulation part 6 is packed as a product in a state in whichthe jig 9 is inserted from the proximal end side thereof.

If the state in which the entire tissue-fastening tool 2 is loaded inthe needle tube 4 is set as a packing state, a state in which thetissue-fastening tool 2 is extended by the needle tube 4 continues for along period of time. As a result, there is a possibility that arestoring force applied to the tissue-fastening tool 2 in advance torestore the coiled curved shape is weakened. When the tissue-fasteningtool 2 is independently packed separately from the main manipulationpart 6, it is necessary for a user to perform a task of coupling theproximal end portion of the tissue-fastening tool 2 and the distal endportion of the stylet 5. However, since the tissue-fastening tool 2 is avery small member, the coupling task requires skill and time.

In consideration of the reduction of the shape restoring force of thetissue-fastening tool 2 and difficulty of a loading task, in the presentembodiment, as described above, the packing is performed in a state inwhich only the proximal end region of the tissue-fastening tool 2engaged with the stylet 5 is inserted into the needle tube 4, and thedistal end region thereof is exposed from the needle tube 4. This stateis referred to as an initial state in this description. An example of aprocedure for setting the initial state will be described below.

When the stylet 5 is moved to the extreme distal end side, the distalend engagement part 51 is exposed from the needle tube insertion passage41. In this state, the initial state (packing state) is set by theprotruding part 51 b being engaged with the recessed part 24 of thetissue-fastening tool 2 and by the stylet 5 being moved to the proximalend side to store the distal end engagement part 51 in the needle tube4. In the initial state, a connection state between the tissue-fasteningtool 2 and the stylet 5 is maintained. At this time, a motion of pullingthe stylet 5 using the jig 9 is performed.

The jig 9 is mounted on the main manipulation part 6 in the initialstate (the packing state). FIG. 18 is a perspective view representingthe jig 9. As represented in FIG. 18, the jig 9 includes a jig handle91, a rod-like insertion shaft (a shaft) 92, a jig side coupling part93, and a shaft head 95. The insertion shaft 92 is fixed to a distal endside of the shaft head 95. At the center of the jig handle 91, an openhole which is slightly larger than a diameter of the insertion shaft 92and smaller than the shaft head 95 is formed, and the insertion shaft 92is inserted through the hole. The jig side coupling part 93 has a hookshape which is curved from a distal end of the insertion shaft 92 andextends toward a proximal end side thereof. The jig handle 91 isprovided to be relatively rotatable with respect to the insertion shaft92. A tubular jig stopper 94 is externally mounted on an outerperipheral surface of a proximal end portion of the insertion shaft 92.

In the initial state, the jig side coupling part 93 is locked to thethrough-hole of the proximal end engagement part 56 in the first camtube 61. That is, the tissue-fastening tool 2 and the jig 9 areconnected to each other via the stylet 5.

The proximal end engagement part 56 is disposed on the distal end sideof the first cam tube 61. The insertion shaft 92 passes through theinside of the first cam tube 61 and extends toward the proximal endside, and the jig handle 91 is exposed to the proximal end side of themain manipulation part 6. At this time, the jig stopper 94 is notexternally mounted on the insertion shaft 92. The insertion shaft 92 hasa length that is greater than or equal to a length from the proximal endengagement part 56 to the proximal end of the Luer joint 57 when thestylet 5 is located at the extreme distal end side with respect to theneedle tube 4. At this time, since the distal end of the stylet 5 isexposed to the outside of the needle tube 4 as described above, thedistal end of the stylet 5 is engaged with the tissue-fastening tool 2.The proximal end region of the tissue-fastening tool 2 is drawn into theneedle tube 4 by pulling the jig 9 slightly toward the proximal end sideto set the initial state. However, since there is a risk that the jig 9moves toward the distal end side and the tissue-fastening tool 2 isdetached in this state, the jig stopper 94 is mounted to prevent the jig9 from moving to the distal end side in order to prevent the risk. Sincea notch 941 is formed on the jig stopper 94 in the direction of thecentral axis L, the jig stopper 94 can be externally mounted on theinsertion shaft 92 from a side thereof. Thus, the initial state (thepacking state) is completed. After being sterilized by the manufacturer,a product is shipped.

First, a user performs a preparatory process (step S1) of pulling andentirely putting the tissue-fastening tool 2 into the needle tube 4.Here, the term “a user” refers to an operator and an assistant whoassists a treatment of the operator. The preparatory process may beperformed by the operator or by the assistant. In the followingdescription, a rotational direction when the user performs a rotationalmanipulation of each part of the main manipulation part 6 and theauxiliary manipulation part 7 is represented as a rotational directionviewed from the proximal end to the distal end in the direction of thecentral axis L.

First, the user rotates the first rotation knob 66 of the mainmanipulation part 6 in a clockwise direction. When the first rotationknob 66 rotates in the clockwise direction, the Luer joint 57 and thefirst cam tube 61 fixed to the Luer joint 57 move to the proximal endside. Since the first engaging pin 55 of the stylet 5 is engaged withboth the first guide passage 612 and the guide slit 673 of the needleguide 67, when the first cam tube 61 moves toward the proximal end side,the stylet 5 also moves toward the proximal end side. As a result, thetissue-fastening tool 2 is pulled toward the proximal end side withinthe needle tube 4. When the user continues to rotate the first rotationknob 66 clockwise, the female screw 661 comes in contact with a distalend side terminal of the male screw 572 of the Luer joint 57 screwedinto the female screw 661, the first rotation knob 66 cannot rotate anymore, and the movement of the Luer joint 57 to the proximal end sidecannot be performed. Thus, the user perceives that the substantiallyintermediate part of the tissue-fastening tool 2 in the longitudinaldirection has been drawn into the needle tube 4.

Next, the tissue-fastening tool 2 is drawn into the needle tube 4 usingthe jig 9. When the user pulls the jig handle 91 of the jig 9 toward theproximal side in the direction of the central axis L, a pulling force ina proximal end direction acts on the stylet 5. At this time, since thefirst engaging pin 55 slides along the first guide passage 612, thestylet 5 moves toward the proximal end side while rotating, and thetissue-fastening tool 2 is further drawn into the needle tube 4. The jighandle 91 is provided to be relatively rotatable with respect to theinsertion shaft 92. Therefore, at a time of a manipulation in which theuser pulls the jig handle 91 in the direction of the central axis L, theinsertion shaft 92 rotates relative to the jig handle 91 to followrotation of the stylet 5. At this time, since the first engaging pin 55is also engaged with the guide slit 673 of the needle guide 67, theneedle guide 67 is simultaneously rotated. Since the tissue-fasteningtool 2 generates a strong force to return to an original coil shapethereof by being drawn into the needle tube 4, the needle tube 4receives the strong force from the tissue-fastening tool 2. Therefore,the movement of the needle tube 4 in the rotational direction may bemade to follow the movement of the tissue-fastening tool 2 in order toeasily draw the tissue-fastening tool 2 into the needle tube 4.Therefore, the needle tube 4 is attached to the needle guide 67 to berelatively rotatable and not to be advanceable and retractable. Thetissue-fastening tool 2 can be loaded into the needle tube 4 whilerotating due to the motion of pulling the jig handle 91 toward theproximal end side in a linear direction along the central axis L.

When the user continues to draw the jig 9 toward the proximal sidefurther, the tissue-fastening tool 2 is gradually stored in the needletube 4, and one of the first engaging pins 55 that is disposed closestto the proximal end side comes in contact with an end surface on thedistal end side of the Luer joint 57 immediately after the distal end ofthe tissue-fastening tool 2 is stored in the needle tube 4. Therefore,the stylet 5 can no longer move toward the proximal end side, and thejig 9 can no longer be drawn toward the proximal side. As a result, theuser perceives that the loading of the tissue-fastening tool 2 has beencompleted. At the same time, since the proximal end engagement part 56is exposed to the outside, the operator releases the engagement betweenthe jig 9 and the proximal end engagement part 56 to detach the jig 9.Thus, the preparatory process is completed.

In this way, in the indwelling device 1 according to the presentembodiment, since the tissue-fastening tool 2 is loaded using the jig 9,it is not required to provide a mechanism for drawing thetissue-fastening tool 2 into the needle tube 4 in the main manipulationpart 6, and it is possible to reduce a size of the main manipulationpart.

Next, the main manipulation part 6 is mounted on the endoscope 100 andfixed thereto (step S2). The sheath 3 and the needle tube 4 are insertedinto the treatment tool channel 102 of the endoscope insertion part 101,and as represented in FIG. 19, the main manipulation part 6 is fixed tothe manipulation part 104 of the endoscope 100 by the mounting part 69provided at the distal end of the sheath slider 63 of the mainmanipulation part 6 being screw-engaged with the port 103 of thetreatment tool channel 102 of the endoscope 100. In step S2, theoperator and the assistant cooperate to perform the manipulation.

Manipulations from step S3 to step S9 are performed by the operator.FIGS. 20 to 26 are diagrams representing aspects on the distal end sideof the endoscope insertion part 101 when using the indwelling device 1.As represented in FIG. 20, the operator inserts the endoscope insertionpart 101 into a treatment target part in a body (step S3). A distal endof the endoscope insertion part 101 is inserted into the vicinity of thetissue D of the duodenum which is a target tissue.

Steps S2 and S3 may be performed in reverse order.

Next, a position of the distal end of the sheath 3 with respect to thedistal end of the endoscope insertion part 101 is adjusted (step S4).The operator loosens the fixing knob 634 and advances and retracts themain manipulation part main body 62 in the direction of the central axisL with respect to the sheath slider 63 to adjust the position of thedistal end of the sheath 3 in the direction of the central axis L sothat the position becomes a feasible position with respect to the distalend of the endoscope insertion part 101. FIG. 20 represents a state inwhich the distal end position of the sheath 3 in the direction of thecentral axis L coincides with the distal end of the endoscope insertionpart 101. When the distal end position of the sheath 3 is determined,the operator tightens the fixing knob 634 to fix the position of thesheath 3.

As represented in FIG. 21, the operator brings the endoscope insertionpart 101 and the distal end opening portion 32 of the sheath 3 intocontact with the tissue D of the duodenum. An ultrasonic transducer 101a is provided at the distal end of the endoscope insertion part 101.Therefore, in a subsequent treatment, a state in which the distal end ofthe endoscope insertion part 101 is in contact with the tissue D of theduodenum is maintained, and the operator performs the treatment whilechecking an ultrasonic image.

Subsequently, an amount of protrusion of the needle tube 4 from thedistal end opening portion 32 of the sheath 3 in the direction of thecentral axis L is set (step S5). When the operator loosens the needlestopper screw 652, the needle slider stopper 65 can slide. After theoperator slides the needle slider stopper 65 toward the distal end sidedepending on a length (amount of protrusion of the needle tube 4 fromthe sheath 3) by which the puncturing part 42 of the needle tube 4 isdesired to puncture into the tissue, the operator tightens the needlestopper screw 652 to fix the needle slider stopper 65. By themanipulation, a puncture length of the puncturing part 42 of the needletube 4 is set. At this time, the movement of the needle slider 64 isrestricted by the slide button unit 68, and the needle slider 64 doesnot move linearly.

Next, as represented in FIG. 22, the puncturing part 42 of the needletube 4 punctures the target tissue (step S6). When the operator pushesthe button main body 682 of the slide button unit 68 toward the side ofthe central axis L, a restriction of an advancement and retractionmovement of the needle slider 64 is released, and the needle slider 64enters a state of being advanceable and retractable in the direction ofthe central axis L with respect to the main manipulation part main body62. Thereafter, the operator advances the needle slider 64 in a lineardirection until it comes into contact with the needle slider stopper 65.Since the needle slider 64 and the needle tube 4 are connected to eachother via the needle guide 67 such that relative positions thereof inthe direction of the central axis L are invariable, the needle tube 4advances with the advancement of the needle slider 64. As a result, thepuncturing part 42 of the needle tube 4 protrudes from the distal end ofthe sheath 3 and punctures the tissue D of the duodenum and the tissueCBD of the common bile duct, which are target tissues. When the operatorreleases his or her finger from the slide button unit 68, the slidebutton unit 68 moves in a direction which separates the button main body682 from the outer side of the needle slider 64 in the radial directionby an urging force of the spring member 683, and the locking pin 684 cis pressed against the outer surface of the main manipulation part mainbody 62.

Next, the tissue-fastening tool 2 is indwelled into a common bile ductside (step S7). As represented in FIG. 23, the tissue-fastening tool 2is protruded from the needle tube 4. The operator rotates the firstrotation knob 66 counterclockwise.

When a counterclockwise rotational manipulation of the first rotationknob 66 is started, the needle slider 64 also rotates counterclockwisewith the first rotation knob 66 until the locking pin 684 c of the plate684 is engaged with the helical groove 622 of the main manipulation partmain body 62. As soon as the locking pin 684 c is engaged with thehelical groove 622, the needle slider 64 tries to advance toward thedistal end side while rotating in accordance with the helical groove622. However, the needle slider 64 can neither rotate nor advance sincethe needle slider 64 is in contact with the needle slider stopper 65.Therefore, only the first rotation knob 66 rotates after the locking pin684 c is engaged with the helical groove 622. When the first rotationknob 66 rotates with respect to the needle slider 64, the Luer joint 57and the first cam tube 61 are linearly sent to the distal end side. Atthis time, since the end surface on the distal end side of the Luerjoint 57 and one of the first engaging pins 55 at the extreme proximalend side come into contact with each other, the stylet 5 is linearlysent to the distal end side. As a result, a distal end side region of acoil of the tissue-fastening tool 2 is linearly sent from the distal endof the needle tube 4 into the common bile duct.

When a proximal end side end surface of the linear groove 573 of theLuer joint 57 comes into contact with a proximal end side end surface ofthe engaging projection 643 b of the needle slider end member 643, theLuer joint 57 can no longer move toward the distal end side and thefirst rotation knob 66 does not rotate. A distance in the direction ofthe central axis L between the proximal end side end surface of thelinear groove 573 of the Luer joint 57 and the proximal end side endsurface of the engaging projection 643 b of the needle slider end member643 is set depending on a predetermined length at which thetissue-fastening tool 2 is sent on the common bile duct side. Therefore,as the first rotation knob 66 does not rotate, the operator can perceivethat the process of indwelling the predetermined length of the coil ofthe tissue-fastening tool 2 on the common bile duct side is completed.

Next, as represented in FIG. 24, the needle tube 4 is removed from thetissue CBD of the common bile duct and the tissue D of the duodenum(step S8). When the needle tube 4 is removed, as the distal end of theneedle tube 4 is pulled out of the tissue CBD of the common bile duct, acoil part 2 a of the tissue-fastening tool 2 is inclined and acircumferential direction of the coil comes into close contact with thetissue CBD of the common bile duct. At this time, since there is a casein which the coil part 2 a is inclined in a direction different from apredetermined direction of the coil, a manipulation of correcting adirection of the coil part 2 a to the predetermined direction isnecessarily performed.

The operator rotates the needle slider 64 clockwise. Since the lockingpin 684 c of the plate 684 is engaged with the helical groove 622 of themain manipulation part main body 62, when the needle slider 64 isrotated clockwise, the needle slider 64 moves toward the proximal endside while rotating along the helical groove 622. The Luer joint 57 andthe first cam tube 61 also move toward the proximal end side whilerotating clockwise together with the needle slider 64. Since the firstguide passage 612 of the first cam tube 61 is formed in a right screwdirection, by clockwise rotation of the first cam tube 61, an innersurface of the first guide passage 612 imparts a vector force in adirection of the proximal end side to the first engaging pin 55 of thestylet 5.

At this time, since the one of the first engaging pins 55 on the extremeproximal end side is in contact with the end surface on the distal endside of the Luer joint 57, the stylet 5 basically moves toward theproximal end side while rotating clockwise together with the needleslider 64. At this time, the needle guide 67 also moves toward theproximal end side while rotating clockwise together with the needleslider 64. Since the needle tube 4 is rotatably supported by the needleguide 67, the needle tube 4 moves toward the proximal end side togetherwith the needle slider 64, but the movement of the needle tube 4 in therotational direction is not related to the needle slider 64. In anactual procedure, since the endoscope insertion part 101 has a complexcurved shape, the needle tube 4 inserted into the treatment tool channel102 is also curved into a complicated shape. As described above, amaterial of the needle tube 4 is a metal tube, and it is difficult toperform a manipulation which rotates the needle tube 4 in a state ofbeing curved into the complicated shape because a very strong force isnecessary. Therefore, even if the needle slider 64 moves toward theproximal end side while rotating, the needle tube 4 is configured toonly follow movement toward the proximal end side without rotating.

As represented in FIG. 6A, the sheath 3 is fixed to the sheath guide 623via the sheath fixing part 625. The sheath guide 623 is rotatablysupported by the main manipulation part main body 62.

As represented in FIG. 6D, the first slit 623 b of the sheath guide 623is fitted onto the rib 673 a formed on the radial outside of thecircumference of the guide slit 673 of the needle guide 67 to followonly the rotational direction. With such a configuration, when theneedle slider 64 is moved toward the proximal end side while beingrotated clockwise, the sheath 3 only follows the rotation.

With the aforementioned motion, the sheath 3 and the stylet 5 rotatewhile the needle tube 4 is pulled back. When the puncturing part 42 ofthe needle tube 4 is stored in the lumen 31 of the sheath 3, the wire ofthe tissue-fastening tool 2 enters the notched part 33 of the sheath 3.When the sheath 3 rotates in a predetermined direction in a state inwhich the wire of the tissue-fastening tool 2 is locked to the notchedpart 33, the coil part 2 a indwelled in the common bile duct siderotates, and the direction of the coil part 2 a is corrected to adesired state.

As described above, in step S8, the stylet 5 moves toward the proximalend side while rotating, and at the same time, the needle tube 4 movestoward the proximal end side without rotating. By this manipulation,since the stylet proximal end member 54 to which the stylet 5 isconnected receives from the first cam tube 61 a vector in the directiontoward the proximal end side, the stylet 5 and the needle tube 4 arepulled back toward the proximal end side. At this time, in a state inwhich the distal end opening portion 32 of the sheath 3 comes intocontact with the target tissue, the coil part 2 a of thetissue-fastening tool 2 indwelled in the common bile duct side acts asan anchor, and the tissue-fastening tool 2 simultaneously receives aforce pulling in a direction of the distal end. When a force which pullsthe stylet 5 toward the proximal end side increases, there is a riskthat a force applied to the target tissue by the target tissue beingsandwiched between the tissue-fastening tool 2 and the sheath 3 becomesstronger and the tissue is compressed due to an excessive load.

In the indwelling device 1 according to the present embodiment, in orderto prevent an excessive load to the target tissue, when a forcesandwiching the target tissue between the tissue-fastening tool 2 andthe sheath 3 becomes stronger, synchronization of the stylet 5 with themovement of the needle slider 64 moving in the proximal end directionwhile rotating clockwise is released, and the force sandwiching thetarget tissue between the tissue-fastening tool 2 and the sheath 3 isrelieved. As described above, the first guide passage 612 imparts thevector force in the direction of the proximal end side to the firstengaging pin 55 of the stylet 5. However, when a force in the distal enddirection from the tissue-fastening tool 2 becomes stronger than thevector force, the synchronization between the stylet 5 and the needleslider 64 is released, only the needle tube 4 moves toward the proximalend side, and the first engaging pin 55 moves in the distal enddirection along the first guide passage 612. At this time, since thestylet 5 moves relative to the distal end side with respect to theneedle slider 64, the load can be weakened. As a result, if the force inthe distal end direction from the tissue-fastening tool 2 is lower thanthe vector force in the proximal end direction, the stylet 5 enters astate of following the movement of the needle slider 64 again. In thisway, it is possible to prevent damage to the tissue of the treatmenttarget site. A motion of automatically adjusting the load can beachieved by suitably setting the lead angle of the first guide passage612. Specifically, the motion can be achieved by setting the lead anglewithin the range of 20 degrees to 75 degrees.

When the lead angle of the first guide passage 612 is smaller than 20degrees, since the vector force in the proximal end side directionimparted to the first engaging pin 55 becomes stronger, forces are firstbalanced when the force in the distal end direction from thetissue-fastening tool 2 becomes very strong. Thus, there is apossibility that the sandwiched tissue is damaged. When the lead angleof the first guide passage 612 is larger than 75 degrees, since thevector force in the proximal end side direction imparted to the firstengaging pin 55 becomes weaker, the forces are balanced in a state inwhich the force in the distal end direction from the tissue-fasteningtool 2 is very weak. Thus, there is a possibility that the stylet 5cannot be sufficiently pulled to the proximal end side. Further, it ismore preferable that the lead angle be in the range of 40 degrees ormore. This is because the larger the lead angle is, the smaller thediameter of the first cam tube 61 can be set. By reducing the diameterof the first cam tube 61, it is possible to reduce the diameter andweight of the main manipulation part 6.

In step S8, since the needle slider 64 does not rotate when the lockingpin 684 c moves toward the proximal end of the helical groove 622, theoperator can perceive that the needle tube 4 has been removed from thetissue.

Next, as represented in FIG. 25, the sheath 3, the needle tube 4, andthe stylet 5 are advanced by a predetermined distance (step S9). In astate in which the distal end portion of the sheath 3 comes into contactwith the tissue D of the duodenum, the operator loosens the fixing knob634 and advances the fixing knob 634 until the fixing knob 634 comesinto contact with the distal end of the second slit 633. Thus, the mainmanipulation part main body 62 comes into contact with the distal end ofthe sheath slider 63. By this manipulation, the sheath 3 moves to thedistal end side of the mounting part 69.

Since the mounting part 69 is fixed to the endoscope 100, the sheath 3is extruded from the distal end of the endoscope insertion part 101, andthe endoscope insertion part 101 relatively retracts and the distal endthereof is separated from the tissue D of the duodenum. In thesubsequent treatment, a surgical field is imaged by an optical imagingdevice (not represented) provided at the distal end of the endoscopeinsertion part 101. The operator performs the treatment while checkingthe endoscopic image.

In step S9, a force in a direction of retracting toward the proximal endside is generated in the main manipulation part main body 62. However,since the screw part 634 a of the fixing knob 634 is pressed by theresin spring 635 of the sheath slider 63, it is possible to prevent themain manipulation part main body 62 from retracting.

Since the main manipulation part main body 62 can no longer advance whenthe fixing knob 634 comes into contact with the distal end of the secondslit 633, the operator can perceive that the main manipulation part mainbody 62 has been pushed into a predetermined position. Further, sincethe main manipulation part main body 62 does not unintentionally movetoward the proximal end side due to the function of the resin spring 635even if the fixing knob 634 is not tightened, the position of the mainmanipulation part main body 62 does not deviate from the predeterminedposition.

The next step S10 is performed by the assistant and the operatorcooperating. Manipulations subsequent to step S11 are performed by theassistant manipulating the auxiliary manipulation part 7. That is, themanipulation of sending the coil of the tissue-fastening tool 2 to theduodenum side is performed by the auxiliary manipulation part 7.

The auxiliary manipulation part 7 is connected to the main manipulationpart 6 (step S10). The assistant holds the auxiliary manipulation part 7and inserts the proximal end of the Luer joint 57 of the mainmanipulation part 6 into the distal end opening of the sixth insertionpassage 711 of the manipulation coupling part 71. When the operator orthe assistant rotates the manipulation coupling part 71, the screwgroove 712 of the sixth insertion passage 711 and the flange 574 formedat the proximal end portion of the Luer joint 57 are screwed together,and the main manipulation part 6 and the auxiliary manipulation part 7are connected to each other. When the rotation handle 74 is rotatedclockwise, the rotation handle 74 advances while rotating to follow thesecond guide passage 731 formed in the second cam tube 73. Since thetransmission member 8 is fixed to the rotation handle 74 via the fixingmember 744, the transmission member 8 advances while rotating clockwise.Since the stylet engagement part 82 of the transmission member 8advances while rotating, the stylet engagement part 82 comes intocontact with the proximal end engagement part 56 of the stylet 5 in ashort time. As represented in FIG. 8, the proximal end portion 56 a hasa shape that protrudes toward the proximal end side on the central axisL. Therefore, in a state in which the stylet engagement part 82 of thetransmission member 8 and the proximal end of the proximal endengagement part 56 of the stylet 5 come into contact with each other,the transmission member 8 advances while rotating. Thus, the proximalend engagement part 56 of the main manipulation part 6 is fitted andengaged between the two arms 82 b of the stylet engagement part 82.Thereafter, the rotation and the advance driving of the transmissionmember 8 can be transmitted to the stylet 5.

As represented in FIG. 19, since the main manipulation part 6 and theauxiliary manipulation part 7 are coupled to each other by a flexiblepart including the cable tube 81 and the transmission member 8,adaptability can be given to a positional relationship between the mainmanipulation part 6 and the auxiliary manipulation part 7. Thus, theassistant can perform the manipulation without disturbing the operatorby standing at a location where it is easy to operate the auxiliarymanipulation part 7. Since there is the flexible part between the mainmanipulation part 6 and the auxiliary manipulation part 7, the mainmanipulation part 6 is not strongly pushed even if the assistantstrongly pushes the auxiliary manipulation part 7 in the distal enddirection of the central axis L. Therefore, for example, it is possibleto prevent an accident such as an extrusion of the needle tube 4 towardthe distal end side due to a careless motion of the assistant without anintention of the operator.

Next, the tissue-fastening tool 2 is indwelled in a lumen constituted ofthe tissue D of the duodenum (step S11). When the assistant rotates therotation handle 74 clockwise, the transmission member 8 advances whilerotating clockwise.

Specifically, as represented in FIG. 14A, when the rotation handle 74 isrotationally manipulated, the second engaging pin 743 moves along theinside of the second guide passage 731, and the rotation handle 74 movesrelative to the distal end side with respect to the second cam tube 73and approaches the auxiliary manipulation part main body 72. Further,when the rotation handle 74 is rotationally manipulated, the distal endportion of the rotation handle 74 enters the gap S between the secondcam tube 73 and the auxiliary manipulation part main body 72 inside thefirst region 721 a of the seventh insertion passage 721.

When the rotation handle 74 is rotationally manipulated as describedabove, the transmission member 8 is configured to advance while rotatingwith respect to the auxiliary manipulation part 7 and to protrude fromthe manipulation coupling part 71. As a result, the helical movement (ahelical input) of the transmission member 8 is transmitted to the stylet5.

The helical pitch P1 of the first guide passage 612 of the first camtube 61 is equal to the helical pitch P2 of the second guide passage 731of the second cam tube 73. Rotational directions of the first guidepassage 612 and the second guide passage 731 are also equal to eachother in the clockwise direction. The indwelling device 1 is providedwith the main manipulation part 6 and the auxiliary manipulation part 7as separate bodies, and the manipulation of the auxiliary manipulationpart 7 is transmitted to the main manipulation part 6 via thetransmission member 8. Further, in consideration of manipulationproperties when the main manipulation part 6 and the auxiliarymanipulation part 7 are manipulated by different persons, thetransmission member 8 may have flexibility and may have a long length insome cases. In this case, there is a deviation between the movement ofthe rotation handle 74 and the movement of the stylet engagement part 82due to an influence of bending and length of the transmission member 8in the transmission path of the driving force, so that there is apossibility that movement may not be accurately transmitted to thestylet 5.

However, in the indwelling device 1 according to the present embodiment,since the first guide passage 612 and the second guide passage 731 areformed at the same helical pitch and in the same rotational direction, arotating motion transmitted from the transmission member 8 can beadjusted to be the same rotational movement amount as the movement ofthe rotation handle 74 in the first guide passage 612. Therefore, aninput in a helical direction generated by the rotational manipulation ofthe auxiliary manipulation part 7 is accurately output from the stylet 5as a helical motion.

As described above, when the rotation handle 74 is rotationallymanipulated, the first engaging pin 55 of the stylet 5 rotates theneedle guide 67 and the needle guide 67 rotates the sheath guide 623.Thus, the sheath 3 rotates in synchronization with the rotation of thestylet 5. As illustrated in FIG. 26, in step S11, since thetissue-fastening tool 2 enters the notched part 33 of the sheath 3, thetissue-fastening tool 2 is pushed out from the needle tube 4 while beingrotated by the sheath 3 and the stylet 5. At this time, the needle tube4 does not rotate as described above. When the one of the first engagingpins 55 of the stylet 5 at the extreme distal end side comes intocontact with the distal end of the first guide passage 612 of the firstcam tube 61, the advancement of the stylet 5 is completed. At this time,the distal end of the stylet 5 is exposed to the outside of the needletube 4.

Thus, the engagement between the implant-coupling part 22 of thetissue-fastening tool 2 and the distal end engagement part 51 of thestylet 5 is released (step S12), and the indwelling of thetissue-fastening tool 2 is completed. As described above, the indwellingdevice 1 is configured such that the distal end of the stylet 5 isexposed from the distal end of the needle tube 4 when both of the mainmanipulation part 6 and the auxiliary manipulation part 7 perform themotion (the first motion) in which the tissue-fastening tool 2 isdischarged from the distal end of the needle tube 4 by the stylet 5being advanced with respect to the needle tube 4.

According to the present embodiment, after the needle tube 4 is removedfrom the tissue and stored in the sheath 3, coil indwelling on theduodenum side is performed by the auxiliary manipulation part 7. Thatis, it is possible to separately perform a plurality of manipulations ofthe main manipulation part 6 and the auxiliary manipulation part 7 toindwell the tissue-fastening tool 2 in the treatment target tissue.Thus, the main manipulation part 6 can be reduced in size in comparisonto a conventional implant-indwelling device. Therefore, it is possibleto improve manipulation properties of the operator.

Furthermore, the manipulation related to the advancement and retractionof the needle tube 4 can be performed only by the main manipulation part6, and a manipulation of the auxiliary manipulation part 7 is performedin a state in which the puncturing part 42 of the needle tube 4 isstored in the sheath 3. Therefore, only the operator can control themovement of the needle tube 4, and the puncturing part 42 cannot damagethe tissue by the manipulation of the assistant. Therefore, a highlysafe treatment can be performed.

According to the present embodiment, the main manipulation part isprovided with the first helical mechanism, and the auxiliarymanipulation part is provided with the second helical mechanism.Therefore, it is possible to output a manipulation that is input to theauxiliary manipulation part to the manipulation transmission member as amotion of the second helical mechanism in a predetermined helicaldirection. In addition, a motion which is input from the manipulationtransmission member to the main manipulation part is once adjusted dueto passing through the first helical mechanism, and is output as amotion in the predetermined helical direction from the stylet.Therefore, even if there is an error in an input motion input to theauxiliary manipulation part and an output motion output from theauxiliary manipulation part caused by a long drive transmission pathbetween the main manipulation part and the auxiliary manipulation part,it is possible to adjust the error by the first helical mechanism again.Therefore, a helical motion which is input to the auxiliary manipulationpart is transmitted to the tissue-fastening tool via the mainmanipulation part with high accuracy.

According to the present embodiment, since the lead angle of the firstguide passage is set in the range of 20 degrees or more and 75 degreesor less, when a force sandwiching a target tissue between thetissue-fastening tool and the sheath becomes stronger, synchronizationbetween the retraction of the needle tube and the retraction of thestylet is released. Therefore, it is possible to prevent an excessiveload from being applied to the target tissue when removing the needletube. More preferably, the lead angle is set in the range of 40 degreesor more. Since this enables a decrease in the diameter of the first camtube, it is possible to reduce the diameter and weight of the mainmanipulation part.

According to the present embodiment, since the state in which thetissue-fastening tool is protruded from the distal end of the needletube and packed is the initial state, the state in which thetissue-fastening tool is stretched within the needle tube for a longperiod of time is not maintained, and the fastening force of thetissue-fastening tool can be maintained in a suitable state.

Furthermore, the tissue-fastening tool in the packing state can beeasily loaded using the jig. In the indwelling device according to thepresent embodiment, since the tissue-fastening tool is loaded using thejig, there is no need to provide the main manipulation part with amechanism which draws the tissue-fastening tool into the needle tube,and the size of the main manipulation part can be reduced.

In the present embodiment, although the implant-indwelling device 1 isdescribed using an example of the endoscopic treatment tool, theendoscopic treatment tool is not limited thereto. For example, aconfiguration such as a suction biopsy needle may be provided in which aspecific motion in a treatment tool can be performed by a manipulationinput from the auxiliary manipulation part in a state in which the mainmanipulation part and the auxiliary manipulation part are coupled toeach other. When the endoscopic treatment tool is a suction biopsyneedle, an example in which the biopsy needle is manipulated only by themain manipulation part and the stylet is manipulated by the mainmanipulation part and the auxiliary manipulation part exists.

Although the present embodiment describes the configuration in which themain manipulation part 6 and the auxiliary manipulation part 7 can beseparated as an example, the main manipulation part and the auxiliarymanipulation part may be configured to be inseparable, for example, byintegrally configuring the stylet 5 and the transmission member 8.

The present embodiment describes an example in which the protruding part51 b is provided on the distal end engagement part 51, the recessed part24 is provided in the implant-coupling part 22, and the stylet 5 and thetissue-fastening tool 2 are connected to each other by the protrudingpart 51 b being engaged with the recessed part 24. However, aconfiguration in which the recessed part is provided in the distal endengagement part and the protruding part is provided in the implantengagement part may be adopted.

Although the present embodiment describes an example in which the threefirst engaging pins 55 are provided on the stylet proximal end member54, the number of the first engaging pins is not limited to three, andat least one first engaging pin may be provided.

Although the present embodiment describes an example in which the firstguide passage 612 is a hole communicating the inside and outside of thefirst cam tube 61 and the second guide passage 731 is a groove having abottom formed on the outer peripheral surface of the second cam tube 73,for example, the second guide passage may be a hole.

While the embodiments of the present invention have been described indetail with reference to the drawings, the specific configuration is notlimited to the embodiments and includes design changes and the likewithin a scope that does not depart from the gist of the presentinvention.

Further, the constituent elements described in each of the embodimentsand each of the modified examples can be constituted by appropriatelycombining them.

The present invention is not limited by the foregoing description, andis only limited by the appended claims.

What is claimed is:
 1. An endoscopic treatment tool, comprising: aneedle tube in which a needle tube insertion passage extending from adistal end to a proximal end of the needle tube is formed; a styletwhich is disposed to move freely in the needle tube insertion passage; amain manipulation part which is connected to a proximal end side of theneedle tube, the main manipulation part supporting the stylet such thatthe stylet advances while rotating, and the main manipulation partoperating the stylet; a manipulation transmission member which hasflexibility and the manipulation transmission member is connected to thestylet; and an auxiliary manipulation part which includes a handle fixedto a proximal end portion of the manipulation transmission member andthe auxiliary manipulation part being configured such that themanipulation transmission member advances while rotating in accordancewith a manipulation of the handle.
 2. The endoscopic treatment toolaccording to claim 1, wherein the stylet and the manipulationtransmission member are separable from each other.
 3. The endoscopictreatment tool according to claim 1, further comprising a sheath inwhich a lumen extending from a distal end to a proximal end of thesheath is formed, wherein the needle tube is inserted into the lumen. 4.The endoscopic treatment tool according to claim 1, further comprisingan implant which is connected to the stylet.
 5. The endoscopic treatmenttool according to claim 1, wherein the auxiliary manipulation part isdisposed to be separate from the main manipulation part.
 6. Theendoscopic treatment tool according to claim 3, further comprising: astylet proximal end member which is fixed to a proximal end portion ofthe stylet; and an engagement part which protrudes from an outerperipheral surface of the stylet proximal end member, wherein the mainmanipulation part includes a first cam tube which includes an insertionpassage formed along a longitudinal axis, and in which a first guidepassage is formed in a helical shape around a central axis of theinsertion passage, the stylet proximal end member is inserted into theinsertion passage of the first cam tube, and the endoscopic treatmenttool is configured such that, when the manipulation transmission memberis advanced while being rotated by the auxiliary manipulation part, theengagement part moves while being engaged with the first guide passage,so that the stylet rotates around a central axis of the sheath whileadvancing.
 7. The endoscopic treatment tool according to claim 6,wherein the auxiliary manipulation part includes a second cam tube inwhich a second guide passage is formed in a helical shape at the samehelical pitch and in the same rotational direction as the first guidepassage, the handle includes a second projection which is engaged withthe second guide passage, and the manipulation transmission memberadvances while rotating by the second projection moving while the secondprojection is engaged with the second guide passage.
 8. The endoscopictreatment tool according to claim 7, wherein a lead angle of the firstguide passage is equal to or more than 45 degrees, and the lead angle ofthe first guide passage is equal to or less than 70 degrees.
 9. Theendoscopic treatment tool according to claim 1, wherein the mainmanipulation part includes a first helical mechanism which outputs ahelical motion around a longitudinal central axis to the stylet, theauxiliary manipulation part includes a second helical mechanism whichoutputs a helical motion around a longitudinal central axis to themanipulation transmission member, and the endoscopic treatment tool isconfigured such that a helical motion of the manipulation transmissionmember output by the second helical mechanism is transmitted to thestylet.
 10. The endoscopic treatment tool according to claim 1, furthercomprising a needle slider which is configured to manipulate the needletube such that the needle tube advances or retracts, wherein the styletis configured to advance and retract while rotating with respect to theneedle slider.
 11. The endoscopic treatment tool according to claim 1,wherein the main manipulation part includes a needle guide whichincludes a slit extending in a straight shape along a longitudinal axis,the needle guide freely rotating around a central axis of the needletube relative to the needle tube, and the needle guide being fixed in acentral axial direction of the needle tube relative to the needle tube,and a needle slider which freely rotates relative to the needle guideand the needle slider being fixed in a longitudinal axial direction ofthe needle guide, the endoscopic treatment tool further comprises insidethe needle slider a stylet proximal end member which is fixed to aproximal end portion of the stylet, and an engagement part whichprotrudes from an outer peripheral surface of the stylet proximal endmember and the engagement part being slidably engaged with the slit, andthe stylet is configured to advance and retract while rotating withrespect to the needle slider in a state in which the engagement part isengaged with the slit.